JIANGSU SUYUN MEDICAL MATERIALS CO., LTD.

FDA Device Registration & Listing · Lianyungang Jiangsu, CN · Registration 3003717263

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003717263
FEI Number
3003717263
Entity Name
JIANGSU SUYUN MEDICAL MATERIALS CO., LTD.
City/State/Country
Lianyungang Jiangsu, CN
Establishment Address
No.18, Jinqiao Road, Dapu Industrial Park, Lianyungang Economic Development Zone, Lianyungang Jiangsu 222002, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Jiangsu Suyun Medical Materials Co., Ltd. (Owner Number: 10029900)
Owner / Operator Contact Address
No.18,Jinqiao Road, Dapu Industrial Park, Lianyungang Economic Development Zone, Lianyungang, CN-JS 222002, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

suction catheter; suction catheter kit URO Saf-Gard Extension Tubing Disposable Endometrial Suction Curette OneCath Intermittent Urinary Catheter OneCath Lubricated Intermittent Urinary Catheter gynaecological collector

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BSY Catheters, Suction, Tracheobronchial Anesthesiology Class 1 868.6810 2013-01-11
KNX Collector, Urine, (And Accessories) For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2019-08-19
HHK Curette, Suction, Endometrial (And Accessories) Obstetrics/Gynecology Class 2 884.1175 2011-04-28
EZC Catheter, Coude Gastroenterology, Urology Class 2 876.5130 2018-06-22
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2018-06-22
GEE Brush, Biopsy, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2009-07-13

Official Correspondent

Xu Guang Ning

US Agent Details

Dennis Xu Business: Performance International, Corp. Email: ybx99@yahoo.com Phone: (919) 8590478

Related Public Records

Same Entity

Jiangsu Suyun Medical Materials Co., Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K791969 Medline Industries, Inc. DYNACOR STERILE CLOSED SYS. DRAINAGE BAG 1979-11-05

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-2013 Cure Medical LLC 2
Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003717263. Last updated year: 2026. Please use registration number 3003717263 when referencing this establishment in official correspondence.
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